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Archive for the ‘Population Health Management, Genetics & Pharmaceutical’ Category


Early Details of Brain Damage in COVID-19 Patients

Reporter: Irina Robu, PhD

 

COVID-19 has currently claimed more American lives than World War I, Vietnam War and the Korean war combined. And while it is mainly a respiratory disease, COVID-19 infection affects other organs, including the brain. Researchers at Harvard-affiliated Massachusetts General Hospital found that COVID patients with neurological symptoms show more than some metabolic disturbances in the brain as patients who have suffered oxygen deprivation.

During the course of the pandemic, thousand patients with COVID-19 have been seen at MGH and the severity of the neurological symptoms varies from temporary loss of smell to more severe symptoms such as dizziness, confusion, seizures, and stroke. According to the principal investigator of the study, Eva Maria Ratai, Department of Radiology used 3 Tesla Magnetic Resonance Spectroscopy (MRS) to identify neurochemical abnormalities even the structural imagining findings are normal. COVID-19 patients’ brains showed N-acetyl-aspartate (NAA) reduction, choline elevation, and myo-inositol elevation, comparable to what is seen with these metabolites in other patients with leukoencephalopathy after hypoxia without COVID.

Their research indicated that one of patients with COVID-19 indicate the most severe white matter damage, whereas another had COVID-19 associated necrotizing leukoencephalopathy at the time of imaging. And the patient that experience cardiac arrest showed subtle white matter changes on structural MR. The control cases included one patient with damage due to hypoxia from other causes: one with sepsis-related white matter damage, and a normal, age-matched, healthy volunteer.

The main question still remains whether the decrease in the oxygen of the brain is causing the white matter to change or whether the virus itself is attacking white matter. The conclusion is that MRS can be used as a disease and therapy monitoring tool.

SOURCE

Small study reveals details of brain damage in COVID-19 patients

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Mechanistic link between SARS-CoV-2 infection and increased risk of stroke using 3D printed models and human endothelial cells

Reporter: Adina Hazan, PhD

 

Kaneko, et al.  from UCLA aimed to explore why SARS-CoV-2 infection is associated with an increased rate of cerebrovascular events, including

  • ischemic stroke and
  • intracerebral hemorrhage

While some suggested mechanisms include an overall systemic inflammatory response including increasing circulating cytokines and leading to a prothrombotic state, this may be only a partial answer. A SARS-CoV-2 specific mechanism could be likely, considering that both angiotensin-converting enzyme-2 (ACE2), the receptor necessary for SARS-CoV-2 to gain entry into the cell, and SARS-CoV-2 RNA have been reportedly detected in the human brain postmortem.

One of the difficulties in studying vasculature mechanisms is that the inherent 3D shape and blood flow subject this tissue to different stressors, such as flow, that could be critically relevant during inflammation. To accurately study the effect of SARS-CoV-2 on the vasculature of the brain, the team generated 3D models of the human middle cerebral artery during intracranial artery stenosis using data from CT (computed tomography) angiography. This data was then exported with important factors included such as

  • shear stress during perfusion,
  • streamlines, and
  • flow velocity to be used to fabricate 3D models.

These tubes were then coated with endothelial cells isolated and sorted from normal human brain tissue resected during surgery. In doing so, this model could closely mimic the cellular response of the vasculature of the human brain.

Surprisingly, without this 3D tube, human derived brain endothelial cells displayed very little expression of ACE2 or, TMPRSS2 (transmembrane protease 2), a necessary cofactor for SARS-COV-2 viral entry.

Interestingly,

  • horizontal shear stress increased the expression of ACE2 and
  • increased the binding of spike protein to ACE2, especially within the stenotic portion of the 3D model.

By exposing the endothelial cells to liposomes expressing the SARS-CoV-2 spike protein, they also were able to explore key upregulated genes in the exposed cells, in which they found that

  • “binding of SARS-CoV-2 S protein triggered 83 unique genes in human brain endothelial cells”.

This included many inflammatory signals, some of which have been previously described as associated with SARS-COV-2, and others whose effects are unknown. This may provide an important foundation for exploring potential therapeutic targets in patients susceptible to cerebrovascular events.

Overall, this study shows important links between the

  • mechanisms of SARS-CoV-2 and the
  • increase in ischemic events in these patients. It also has important implications for
  • treatment for SARS-CoV-2, as high blood pressure and atherosclerosis may be increasing ACE2 expression in patients, providing the entry port for viral particles into brain endothelia.

SOURCE:

https://www.ahajournals.org/doi/10.1161/STROKEAHA.120.032764

Other related articles published in this Open Access Online Scientific Journal include the following:

The Impact of COVID-19 on the Human Heart

Reporters: Justin D. Pearlman, MD, PhD, FACC and Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2020/09/29/the-impact-of-covid-19-on-the-human-heart/

 

SAR-Cov-2 is probably a vasculotropic RNA virus affecting the blood vessels: Endothelial cell infection and endotheliitis in COVID-19

Reporter: Aviva Lev-Ari, PhD, RN – Bold face and colors are my addition

https://pharmaceuticalintelligence.com/2020/06/01/sar-cov-2-is-probably-a-vasculotropic-rna-virus-affecting-the-blood-vessels-endothelial-cell-infection-and-endotheliitis-in-covid-19/

 

Diagnosis of Coronavirus Infection by Medical Imaging and Cardiovascular Impacts of Viral Infection, Aviva Lev-Ari, PhD, RN  Lead Curator – e–mail: avivalev-ari@alum.berkeley.edu

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Mysteries of COVID Smell Loss

Reported : Irina  Robu, PhD

When Covid-19 patients have smell loss it tends to be sudden and severe. They are usually don’t have a blocked, stuffy or runny nose – most people with coronavirus can still breathe freely.  Since the epidemy started in march, an estimated of 80 percent of people with COVID-19 have experience smell disturbances in addition to loss of taste and the ability to smell chemical irritants. Research has shown that smell loss is common in people with COVID-19 disease, the reason why researchers and doctors have recommended to use a diagnostic test to determine if a patient has COVID-19.

Yet, the mystery is how the new coronavirus robs patients of their senses. During the early days of the epidemic, physicians and researchers thought that COVID related loss of smell might signal that the virus makes its way into the brain through the nose, where it can do the most severe damage. According to Sandeep Robert Data, a neuroscientist at Harvard Medical School, the research data showed that the primary source is the in the nose, but more specifically in the nasal epithelium. It looks like the virus attacks the cells responsible for registering odors rather than attacking neurons directly.  

It is well known that  olfactory neurons do not have angiotensin-converting enzyme 2 (ACE2) receptors, which permit the virus entry to cells, on their surface. But sustentacular cells, which provide support for  olfactory neurons are scattered with the receptors. These cells preserve the important  balance of salt ions in the mucus that neurons rest on on to send signals to the brain. If that balance is disturbed, it could lead to a closure of neuronal signaling and loss of smell.

The sustentacular cells correspondingly deliver the metabolic and physical support necessary to keep the fingerlike cilia on the olfactory neurons wherever receptors that detect odors are disturbed. Nicolas Meunier, a neuroscientist at the Paris-Saclay University in France determined that disruption of the olfactory epithelium might explain the loss of smell. Yet, it remains unclear if the damage done by the virus or because it invades immune cells.

Since COVID-19 doesn’t cause nasal congestion, researchers have found a few clues about the loss of smell. Taste receptor cells, which detect chemicals in the saliva and sends signals to the brain do not have ACE receptors. They don’t necessarily  get infected by COVID-19, but other support cells in the tongue carry the receptor.

Researchers determined that more clues on  to how the virus obliterates smell. However, some patients have seen that after five months the ability to smell has returned but not as great as expected. That news is welcomed for patients that have suffered loss of smell due to the COVID-19 virus, yet apprehensions about long term loss of smell is a large cause of concern.

SOURCE

https://www.scientificamerican.com/article/mysteries-of-covid-smell-loss-finally-yield-some-answers1/

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Allocation and Prioritization of Vaccine Dose Administration Schedules: Cover more people or Adhere to Immunization Protocol

Curators:

This curation has four parts:

Part 1:

Waiting on the Covid booster would allow more people to be vaccinated sooner.

  • By Michael Segal, MD, PhD

Part 2:

Expert Opinion by Clinical Authority in Practice of Cardiac Imaging:

  • The Voice of Dr. Justin D. Pearlman, MD, PhD, FACC

Part 3:

Expert Opinion by Scientific Authority in Population Biology

  • The Voice of Prof. Marcus W. Feldman, PhD

Part 4:

Summary

  • The Voices of Prof. Stephen J. Williams, PhD and Aviva Lev-Ari, PhD, RN

Introduction

Aviva Lev-Ari
@AVIVA1950

We agree the protocol should not be changed

Quote Tweet

Pearl Freier
@PearlF
FDA’s Peter Marks explained why the 2 dose regimen for Pfizer/BioNtech vaccine shouldn’t be changed to 1 dose in attempt to reach more patients while there’s limited supply. Aside from 95% effectiveness w/ 2 dose regimen based on clinical data, he said no one knows how long 1/n

Pearl Freier
@PearlF

Replying to

1 dose would be effective for & no one knows if only given 1 dose if patient would get an immune response that “would just dwindle” “And we know that can happen because we know already that people who get very mild covid-19 tend to lose their immune responses pretty quickly.” 2/n

Pearl Freier
@PearlF

We need to make sure that those who get the vaccine regimen are people who know they’ve gotten that protection [95% effective]. Because that’s something we know, whereas the other [1 dose] is conjecture. And I would hate for people to change their behavior on the basis of 3/n

Pearl Freier
@PearlF

one dose of vaccine where we don’t know what’s really happening.” Peter Marks/FDA said (6 min mark) youtube.com/watch?v=uePet5 (
Research!America Alliance Member Meeting with Dr. Peter Marks
With several COVID-19 vaccine candidates under FDA review, Dr. Peter Marks, Director of FDA’s Center for Biologics Evaluation and Research (CBER), joined us …
youtube.com

 (she/her/hers)

@lisabari

Replying to

It will be really interesting to learn more about the immune response from J&J’s one dose regimen.

Pearl Freier
@PearlF

I think they’re expecting data from J&J in January

Part 1:

Waiting on the Covid booster would allow more people to be vaccinated sooner.

By Michael Segal, MD, PhD

https://www.wsj.com/articles/a-shot-instead-of-two-at-saving-lives-11607643152

A Shot (Instead of Two) at Saving Lives

Waiting on the Covid booster would allow more people to be vaccinated sooner.

By Michael Segal

Dec. 10, 2020 6:32 pm ET

Recent days brought good news and bad news about coronavirus vaccines. The developments could add up to months of delay in getting most Americans inoculated. But there’s a way to make use of the good news to speed up herd immunity.

The bad news is that in July the U.S. passed up an opportunity to secure by June 2021 more than 100 million doses of the Pfizer vaccine, now expected to receive emergency-use authorization in the next few days. Instead, officials followed a balanced-portfolio strategy that reserved as many as 300 million doses of the AstraZeneca vaccine, whose prospects are unclear.

The good news is that the Pfizer and Moderna vaccines performed at the upper end of expectations, with 95% efficacy after two doses. And intriguingly, Pfizer’s submission to the Food and Drug Administration shows that the efficacy of the vaccine in preventing disease had largely kicked in by two weeks after the first dose, and there was no dramatic increase in efficacy after the booster was given three weeks later.

The protocol in Pfizer’s clinical trial was to give all participants two doses. The FDA is likely to approve this protocol, and standard procedure is to prescribe a drug according to protocol. But we are in a pandemic and supplies of vaccine are inadequate. There’s an alternative: vaccinating as many people as possible with a first dose and waiting on the booster until supplies are plentiful.

The Pfizer study wasn’t designed to put a number on first-dose efficacy, but the data in Pfizer’s “cumulative incidence curves” suggest at least 75% efficacy for two weeks after one dose. The question is whether to use the 100 million doses on 50 million people, of whom two doses would protect roughly 47.5 million, or to give one dose each to 100 million people and protect at least 75 million.

States have the authority to allocate vaccines as they choose, but they’re unlikely to deviate from the study protocol unless a federal authority—whether the Centers for Disease Control and Prevention or a coronavirus “czar”—suggests this as an option.

Even under such an approach, some essential personnel—such as doctors and nurses who work directly with coronavirus patients and health aides who work in multiple nursing homes—should get two doses as soon as possible, given their high-risk role in the pandemic response.

The U.S. will have more than these 100 million doses of the Pfizer vaccine. Some will come from Moderna, and the federal government could use the Defense Production Act to snatch some Pfizer doses that the company contracted to sell to other countries. Even so, supply will be constrained at first, and officials need to think clearly and flexibly about how to allocate the limited doses that will be available soon.

Harvard epidemiologist Michael Mina expressed his disappointment with society’s decision making during the pandemic: “I’m just astounded by the dysfunction, the willingness to just stay the course as hundreds of thousands of people die, and the unwillingness to innovate in literally any way.” Here’s a simple innovation that could save many lives.

Dr. Segal is a neurologist and neuroscientist.

Copyright ©2020 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8

Appeared in the December 11, 2020, print edition.

Part 2:

Expert Opinion by Clinical Authority in Practice of Cardiac Imaging:

The Voice of Dr. Justin D. Pearlman, MD, PhD, FACC

From: Justin MDMEPhD <jdpmdphd@gmail.com>

Date: Saturday, December 12, 2020 at 10:40 PM

To: “Aviva Lev-Ari, PhD, RN” <AvivaLev-Ari@alum.berkeley.edu>

Subject: Re: I NEED YOUR EXPERT OPINION on Mickey Segal’s WSJ op-ed on vaccine dose allocation

Michael Segal proposes off-label use of the Pfizer 2-injection Covid-19 vaccine, based on data that suggested “75% protection at 2 weeks.” There was no controlled study reported of any sustained benefit from the single injection beyond 2 weeks, because those who received a first injection of vaccine received the designed booster at 2 weeks. Dr. Segal suggests it would be irresponsible to use the medication in the manner designed and tested. Instead, he could have proposed a study to determine the duration and degree of benefit from a single dose injection. However, one might argue that could delay the release of an effective regimen for the possibility that his proposed 1 dose regimen might be adequate for some, and possibly for more than the two weeks observed. Even if his guess is correct on both counts, both in his guess that the partial benefit at two weeks might be adequate and that it might last longer than the observed two weeks, it could still be deemed irresponsible to impose his guess for obvious reasons. His guess might be wrong, and could deprive many of the regimen that was validated as effective. Diverting an effective validated regimen to a guess could put many in harms way who would have been protected by the designed 2 dose regimen. He admits to low confidence in his recommendation when he proposes that essential workers should get the validated 2-dose regimen. Why does his recommendation stop there – why not propose a quarter dose to 4 times as many, or 1/8 dose to 8 times as many? Why apply the argument just to the two-dose regimen? He could also guess that a half dose of the single injection successful vaccines might be adequate. The motivation to second guess supply choices and doses is understandable, but it is not sound, as it is just a guess, not a validated regimen.

In addition, he also argues for 20-20 hindsight in the government distributing funds to mulitiple vaccines, instead of disproportionate purchase from Pfizer. Trials are limited in size, and further data will be collected on those vaccinated. Balanced investment may save more lives, not fewer, depending on those outcomes.

On Sat, Dec 12, 2020, 8:20 PM Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu> wrote:

Dear Dr. Pearlman,

Please send me 1/2 –1 page as a Critic of 

  • Mickey Segal’s WSJ op-ed on vaccine dose allocation, below

Part 3:

Expert Opinion by Scientific Authority in Population Biology

The Voice of Prof. Marcus W. Feldman, PhD

From: Marcus W Feldman <mfeldman@stanford.edu>

Date: Sunday, December 13, 2020 at 6:52 PM

To: “Aviva Lev-Ari, PhD, RN” <AvivaLev-Ari@alum.berkeley.edu>

Subject: Re: Mickey Segal’s WSJ op-ed on vaccine dose allocation

RE Segal’s note:

We need more details on the longer term efficacy of the one-dose regimen. Once we have such data, the question of whether 100 million one-dose treatments will be more protective of the population than 50 million two-dose treatments can be addressed. The question of how many hospitalizations and/or deaths would be avoided by going straight to the one-dose regimen can’t be answered. Both approaches leave unanswered whether the transmission of the virus from a vaccinated person is reduced. I would estimate that we need 300 million 2-dose treatments to vaccinate all under 16 year olds.

On Dec 13, 2020, at 1:56 PM, Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu> wrote:

Dear Prof. Feldman,

Please send me 1/2 –1 page as a Critic of 

  • Mickey Segal’s WSJ op-ed on vaccine dose allocation, below

Part 4:

Summary

The Voices of Prof. Stephen J. Williams, PhD and Aviva Lev-Ari, PhD, RN

The Voice of Prof. Stephen J. Williams, PhD

In light of just approved Moderna vaccine, AstraZenaca & JNJ forthcoming vaccine and the approved Pfizer BioNTech coverage should be over 200 million in US, making rationing of second booster shot unnecessary.  However, there is still a concern among the developing and underdeveloped nations that access to these vaccines will be restricted.

The following curation are articles related to this matter from the AAAS and CDC.

CDC advisory panel takes first shot at prioritizing who gets the first shots of COVID-19 vaccines
By Jon CohenDec. 1, 2020 , 8:25 PM
Science’s COVID-19 reporting is supported by the Pulitzer Center and the Heising-Simons Foundation.

Health care workers and elderly people living in long-term care facilities should receive top priority for COVID-19 vaccines in the United States if, as expected, one or more becomes available next month in limited supply. That’s what a group that advises the U.S. Centers for Disease Control and Prevention (CDC) on such fraught issues decided today in a near-unanimous vote.

After hearing detailed presentations from CDC scientists who explained the rationale for this specific prioritization scheme, the Advisory Committee on Immunization Practices (ACIP) voted 13 to one to support their proposal. Under the scheme, the first phase of vaccination, known as 1a, would begin with about 21 million health care workers and about 3 million adults who live in long-term care facilities. As spelled out in the 4-hour-long virtual meeting, these groups are at highest risk of becoming seriously ill or dying from COVID-19, and protecting them first, in turn, reduces the burden on society.

“I agree strongly with the decision of the committee,” says Stanley Perlman, a veteran coronavirus researcher and clinician at the University of Iowa who advised ACIP but is not part of it. “The discussions were incredibly thoughtful with everyone recognizing that we needed to make difficult choices. Of course, these allocation issues will become irrelevant once there are enough doses of useful vaccines.”

‘Just beautiful’: Another COVID-19 vaccine, from newcomer Moderna, succeeds in large-scale trial
By Jon CohenNov. 16, 2020 , 7:00 AM
Science’s COVID-19 reporting is supported by the Pulitzer Center and the Heising-Simons Foundation.

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Now, there are two. Another COVID-19 vaccine using the same previously unproven technology as the vaccine from Pfizer and BioNTech, the U.S. and German companies that reported success on 9 November, appears to work remarkably well. And this time, the maker, U.S. biotech Moderna, is releasing a bit more data to back its claim than the other two companies.

An independent board monitoring Moderna’s 30,000-person vaccine trial met on Sunday and reported to the company and U.S. government health officials that only five people in the vaccinated group developed confirmed cases of COVID-19, whereas 90 people who received placebo shots became ill with the disease. That’s an efficacy of 94.5%, the company reported in a press release this morning. Although the clinical trial measurement may not translate into an equally high level of real-world protection, the success indicates the vaccine is Iikely more than effective enough to stop the pandemic if it can be widely distributed.

“That efficacy is just beautiful, and there’s no question about the veracity of it either,” says Lawrence Corey, a virologist at the Fred Hutchinson Cancer Research Center who co-led the clinical trials network that is testing the vaccine.

Moderna’s COVID-19 vaccine ready to ship pending FDA approval -U.S. health chief

Source: https://www.reuters.com/article/health-coronavirus-usa-azar-idUSKBN28R265?taid=5fdc062c54859c0001437b9b&utm_campaign=trueanthem&utm_medium=trueanthem&utm_source=twitter

WASHINGTON (Reuters) – U.S. Health and Human Services Secretary Alex Azar on Thursday said nearly 6 million doses of Moderna Inc’s experimental COVID-19 vaccine were poised to ship nationwide as soon as it secures Food and Drug Administration approval. Azar, in an interview on CNBC, said federal health officials had allotted 5.9 million doses to send to the nation’s governors, who are managing each state’s distribution. “We’re ready to start shipping this weekend to them for rollout Monday, Tuesday, Wednesday of next week. We’re ready to go,” he said. An FDA panel of outside advisers is weighing the safety and effectiveness of Moderna’s vaccine candidate at a meeting on Thursday. The agency will weigh the committee’s conclusions in making its approval decision.

The strategy seems to have been produce multiple vaccines from multiple sources which reduce the strain on manufacturing of required doses.
However, many underdeveloped nations as well as developing nations are worried about the nationalism of access to these vaccines.  Please read below:

Abstract

The 2030 Agenda for Sustainable Development (AfSD) has the vision to leave no one behind, particularly low-income countries. Yet COVID-19 seems to have brought up new rules and approaches. Through document and critical discourse analysis, it emerges that there has been a surge in COVID-19 vaccines and treatments nationalism. Global solidarity is threatened, with the USA, United Kingdom, European Union and Japan having secured 1.3 billion doses of potential vaccines as of August 2020. Vaccines ran out even before their approval with three candidates from Pfizer-BioNTech, Moderna and AstraZeneca having shown good Phase III results in November 2020. Rich countries have gone years ahead in advance vaccines and treatments purchases. This is a testimony that the 2030 AfSD, especially SDG 3 focusing on health will be difficult to achieve. Low-income countries are left gasping for survival as the COVID-19 pandemic relegates them further into extreme poverty and deeper inequality. The paper recommends the continued mobilisation by the World Health Organisation and other key stakeholders in supporting the GAVI vaccine alliance and the Coalition for Epidemic Preparedness Innovations (COVAX) global vaccines initiative that seeks to make two billion vaccine doses available to 92 low and middle-income countries by December 2021.

Others have voiced their concerns on this matter:

 

Reserving coronavirus disease 2019 vaccines for global access: cross sectional analysis

From: Anthony D So 1 2Joshua Woo 2 BMJ2020 Dec 15;371:m4750. doi: 10.1136/bmj.m4750.

Abstract

Objective: To analyze the premarket purchase commitments for coronavirus disease 2019 (covid-19) vaccines from leading manufacturers to recipient countries.

Design: Cross sectional analysis.

Data sources: World Health Organization’s draft landscape of covid-19 candidate vaccines, along with company disclosures to the US Securities and Exchange Commission, company and foundation press releases, government press releases, and media reports.

Eligibility criteria and data analysis: Premarket purchase commitments for covid-19 vaccines, publicly announced by 15 November 2020.

Main outcome measures: Premarket purchase commitments for covid-19 vaccine candidates and price per course, vaccine platform, and stage of research and development, as well as procurement agent and recipient country.

Results: As of 15 November 2020, several countries have made premarket purchase commitments totaling 7.48 billion doses, or 3.76 billion courses, of covid-19 vaccines from 13 vaccine manufacturers. Just over half (51%) of these doses will go to high income countries, which represent 14% of the world’s population. The US has reserved 800 million doses but accounts for a fifth of all covid-19 cases globally (11.02 million cases), whereas Japan, Australia, and Canada have collectively reserved more than one billion doses but do not account for even 1% of current global covid-19 cases globally (0.45 million cases). If these vaccine candidates were all successfully scaled, the total projected manufacturing capacity would be 5.96 billion courses by the end of 2021. Up to 40% (or 2.34 billion) of vaccine courses from these manufacturers might potentially remain for low and middle income countries-less if high income countries exercise scale-up options and more if high income countries share what they have procured. Prices for these vaccines vary by more than 10-fold, from $6.00 (£4.50; €4.90) per course to as high as $74 per course. With broad country participation apart from the US and Russia, the COVAX Facility-the vaccines pillar of the World Health Organization’s Access to COVID-19 Tools (ACT) Accelerator-has secured at least 500 million doses, or 250 million courses, and financing for half of the targeted two billion doses by the end of 2021 in efforts to support globally coordinated access to covid-19 vaccines.

Conclusions: This study provides an overview of how high income countries have secured future supplies of covid-19 vaccines but that access for the rest of the world is uncertain. Governments and manufacturers might provide much needed assurances for equitable allocation of covid-19 vaccines through greater transparency and accountability over these arrangements.

The Voice of Adina Hazan, PhD

I have a few issues with the proposal and the asserted outcomes:

The author suggests that back in July 2020 “the U.S. passed up an opportunity to secure by June 2021 more than 100 million doses of the Pfizer vaccine…[by] follow[ing] a balanced-portfolio strategy”. By stating that the U.S. “passed up an opportunity” at that time when all available evidence could not indicate which vaccine would prove successful is taking a “hindsight is 2020” approach. Instead, an all-or-nothing portfolio in July 2020 for one vaccine over another would have been at best unwise and at worst could have passed up the “right” vaccine.

In addition, the author’s core suggestion is that every person in America and the world needs the vaccine at the same time, aka as soon as possible. Considering the incredibly striated outcomes of patients that contract COVID-19, this is not the case. We know that males up until 85 years old with have a much worse prognosis than women, for example1. In addition, all data suggests that the lowest risk group is children, with a death rate in the U.S. of 0.1%1. Trying to vaccinate all children with a vaccine whose long-term effects are, at this time, unknown, for a disease with such a low death rate is not urgent and may warrant waiting for more evidence. Instead of trying to inoculate everyone as fast as possible, the two-dose approach that is currently implemented ensures that those most at risk receive the maximum protection, instead of leaving them at higher risks even after vaccination. In this way, the vaccine will do what it was originally intended to do: protect the most vulnerable immediately, and in turn begin to alleviate the strain on the overall population as a result of this disease.

  1. S. CDC website (Deaths by Age Group, 12/18/2020)

The Voice of Aviva Lev-Ari, PhD, RN

  • I recommand to adhere to administration protocol.
  • I agree with Dr. Joel Jertock:

It is very clear that the current COVID vaccination protocols call for two shots, three weeks apart, for maximum protection.

Limiting personnel to a single shot, “to spread the available vaccines further” just means wasting those doses.  It is similar to taking an antibiotic for only 5 days instead of the recommended 10 days, “to make the pills last longer.”

References on Vaccine Development 

Development of Medical Counter-measures for 2019-nCoV, CoVid19, Coronavirus

Read Full Post »


COVID-19 T-cell immune response map, immunoSEQ T-MAP COVID for research of T-cell response to SARS-CoV-2 infection

Reporter: Aviva Lev-Ari, PhD, RN

 

Read our latest blog | T cells: Understanding Exposure and Immunity to COVID-19 by Adaptive Co-Founder and CSO, Harlan Robins. Read here

Watch the video

T cells are the adaptive immune system’s first responders to any virus, circulating in the blood to detect and quickly multiply to attack the virus, often before symptoms appear. Adaptive Biotechnologies’ unique MIRA Technology and immunoSEQ Technology has enabled us to create a comprehensive view of the T-cell response to SARS-CoV-2 infection. This data has been made public as part of the ImmuneCODE Initiative in order to help propel drug, vaccine, and clinical trial research. We are launching immunoSEQ T-MAP COVID with the tools to study and analyze the COVID-19 T-cell immune response map.

SARS-CoV-2-specific Antigen-TCR sequence-level data
Quantitative sequence level data for TCR repertoires for SARS-CoV-2 specific antigens
Monitor immunologic response to SARS-CoV-2 infection or vaccine
Track COVID-19 specific TCR sequences longitudinally
Dive into Patient, Population, or Cohort-level data
Determine TCR clones shared between cohorts & those that are Public vs Private clones

 

Learn more about the science behind the ImmuneCODE database in our first publication (Nolan et al.) and to discover initial COVID-19 data insights, read our recently updated pre-print publication (Snyder et al.)

A large-scale database of T-cell receptor beta (TCRβ) sequences and binding associations from natural and synthetic exposure to SARS-CoV-2

Magnitude and Dynamics of the T-Cell Response to SARS-CoV-2 Infection at Both Individual and Population Levels

End-to-end solution; from experimental design to publication ready data

SARS-CoV-2-specific TCR repertoire sequences & antigen data

✔  Validated TCR-antigen data from over 70 MIRA experiments

✔  In vivo identified SARS-CoV-2-specific TCR sequences

✔  TCR-Antigen sequence level data with the PCR, bias-controlled, reproducible immunoSEQ Assay

Data analysis through the immunoSEQ Analyzer or Computational Biology Services

✔  Explore SARS-CoV-2-specific TCR-Antigen sequence data in the immunoSEQ Analyzer

✔  Compare your COVID-19 samples against our COVID-19 samples to identify public vs private clones

✔  Computational Biology Services for COVID-19 data and Metadata analysis

Comprehensive COVID-19 TCR-Antigen sequence database

✔  Providing you a comprehensive view of SARS-CoV-2-specific antigen and TCR level data

✔  Database will constantly be updated with new findings and TCR-Antigen sequence data

 

Check out the publications below to learn how researchers are propelling their COVID-19 research by leveraging immunoSEQ T-MAP COVID and the ImmuneCODE COVID-19 database

Analysis of SARS-CoV-2 specific T-cell receptors in ImmuneCode reveals cross-reactivity to immunodominant Influenza M1 epitope

 

Watch our video, about how the immunoSEQ Technology and immunoSEQ T-MAP COVID can be used to better understand the immune response to SARS-CoV-2 infection.

 

Ready to learn more about how our immunoSEQ T-MAP COVID service can help you propel your research forward? Contact us below to speak with one of our experts.

SOURCE

https://ww2.adaptivebiotech.com/immunoseq-TMAP-COVID?utm_source=genomeweb&utm_medium=email&utm_campaign=dailynews

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The complication of Pfizer’s Vaccine Distribution’s Plan

Reporter : Irina Robu, PhD

Even though Pfizer announcing the development of safe and effective vaccine is cause for celebration, scientists and public experts face  the challenge of how to quickly make millions of doses of the vaccine and getting them to hospitals, clinics and pharmacies. But Pfizer distribution of vaccines rely on a network of companies, federal and state agencies and on the ground health workers in the midst of a pandemic that is spreading at a high rate in United States.

Before Pfizer can begin shipping its vaccine, federal and state governments must inform Pfizer of how many doses are needed along with syringes, needles and other supplies needed to administer the vaccine. In addition, employees at the locations should be trained to store and administer the vaccine and to ensure that after people are vaccinated, they return for a second dose.

The complication of Pfizer’s vaccine is that it has to be stored at minus 70 degree Celsius until before it is injected.  Pfizer is making the vaccine at facilities in Kalamazoo, Mich., and Puurs, Belgium. The doses distributed in the United States will mostly come from Kalamazoo. When they receive emergency authorization from FDA, Pfizer will send limited doses to large hospitals, pharmacies and other vulnerable groups. At the same time, nine other candidates are also in the final stage of testing.

In Kalamazoo, vaccines will go into vials, vi will go into trays (195 vials per tray) and the trays will go into specially designed cooler-type boxes (up to five trays per box).The reusable boxes, each toting between 1,000 and 5,000 doses and stuffed with dry ice, are equipped with GPS-enabled sensors. Pfizer employees will be able to monitor the boxes’ locations and temperatures as FedEx and UPS transport them to hospitals and clinics nationwide.

The minute Pfizer coolers reach their destinations, hospitals or pharmacies will have a few alternatives of  how to store the vaccine. The easiest option is using ultracold freezers, but they can stash the trays in conventional freezers for up to five days. The destinations can keep the vials in the cooler for up to 15 days as long as they replenish the dry ice and don’t open it more than twice a day.

The chief executives at Pfizer and BioNTech suggest that Pfizer is able to produce up to 50 million doses per year and only half of those will go to US. But since two doses are needed for each person, only 12.5 million doses can be vaccinated.

The other challenge is distributing the vaccine in rural areas, where if not administering the doses fast enough it can go bad. Even though Pfizer has developed and tested an effective vaccine, figuring out how to distribute it is the hardest challenge Pfizer will face.

SOURCE

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12/5/2020

Regeneron’s Covid Antibody coktail has been cleared for emergency use by the FDA. The emergency authorization for REGN-COV2, a combination of monoclonal antibodies casiriviamb and imdevimab, marks the second for the antibody therapy. The first emergency authorization was given to Eli Lily’s bamlanivimab.

The difference that REGN-COV2 is a concoction of several drugs, whereas Lilly’s treatment contains only one drug, the two emergency authorizations  are almost identical. They treat both for mild-to-moderate COVID-19 patients at least 12 years of age who are not hospitalized but are at high risk for progressing to severe COVID-19.

SOURCE

https://www.fiercepharma.com/pharma/regeneron-following-lilly-s-footsteps-wins-fda-emergency-nod-for-covid-19-antibody-cocktail


Regeneron’s new antibody cocktail drug, REGN-COV2

Reporter : Irina Robu, PhD

Regeneron,  leading biotechnology company using the power of science to bring new medicines to patients in need answered quickly to the COVID-19 pandemic and found an antibody cocktail  as the pandemic numbers increase in the U.S. The antibody cocktail, also known as REGN-COV2 antibody combination therapy is an investigational medicine, and its safety and efficacy have not been fully evaluated by any regulatory authority.

REGN-COV2 is being studied in four ongoing late-stage clinical trials: two Phase 2/3 trials for the treatment of hospitalized and non-hospitalized COVID-19 patients, Phase 3 RECOVERY trial of hospitalized COVID-19 patients in the UK, and a Phase 3 trial for the prevention of COVID-19 in uninfected people who are at high-risk of exposure to a COVID-19 patient. The Phase 3 prevention trial is being jointly conducted with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

The company expects approval from FDA on its antibody cocktail and expect to have 2.4-gram doses ready for about 80,000 patients at the end of November and 200,000 doses at the beginning of January.  At the same time, Regeneron partnered with Roche to expand its capacity further by increasing its manufacturing capacity.

Regeneron come in COVID-19 research early this year as the outbreak was in its early stages, testing hundreds of virus-neutralizing antibodies in mice and seeing how they compared with antibodies from human survivors of the novel coronavirus.

SOURCE

https://www.fiercepharma.com/manufacturing/regeneron-predicts-300-000-covid-19-cocktail-doses-ready-by-january-and-substantially

 

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McKinsey experts on COVID-19: Implications for business

 

https://www.mckinsey.com/business-functions/risk/our-insights/covid-19-implications-for-business?cid=other-eml-alt-mip-mck

Reporter on Highlights: Joel T. Shertok, PhD

JTS – 11/17/20

 

  • COVID-19-vaccine trial: a leading candidate has an efficacy rate of about 90 percent.
  • The gap between incoming and outgoing Treasury funds may reach $30 trillion soon.
  • Our latest research shows a particularly effective bridge for governments to consider: real estate.
  • Many businesses will embrace sustainability; voluntary carbon markets can help them reach their goals.
  • China, the world’s growth engine for the past 25 years, has come back
  • Consumer behavior has changed, pockets of growth are shifting, and leadership and management practices are in flux
  • Likely Pandemic scenarios:
  • A muted recovery
  • A prolonged and insufficient recovery
  • As the unrelenting COVID-19 pandemic rolls on, the future isn’t what it used to be: what used to be a simple idea now comes freighted with caveats, assumptions, and speculations.
  • The auto industry is one of the world’s largest and has been devastated by the pandemic: sales may drop by 20 to 30 percent in 2020, and we estimate that profits will fall by $100 billion.
  • The US restaurant industry has given many iconic brands to the rest of the world. But today, the sector is in trouble.
  • People don’t order sides, appetizers, and desserts as frequently when they’re ordering for delivery—but as leaders know, those items are often the difference between profit and loss.
  • For banks, the pandemic has changed everything. Risk-management teams are running hard to catch up with cascades of credit risk, among other challenges.
  • Ethnic minority groups have made progress. But the COVID-19 crisis threatens that progress;
  • All ethnic-minority groups have higher age-adjusted COVID-19-related death rates than white people do.
  • In the middle of the deepest recession in memory, stock markets are reaching new highs. Why the disconnect?
  • Many investors still take a long-term perspective; they are looking ahead to the end of the pandemic.
  • Another factor: five big-tech companies now make up 21 percent of the S&P 500,
  • The overall stock market can do relatively well even when employment and GDP are severely depressed.
  • Companies can expect a disruption to their production lines of one to two months—a very long time.
  • The effects of the COVID-19 crisis have exacerbated gender disparities and their implications for women at work, especially for mothers, female senior leaders, and Black women across America.
  • The exodus might include as many as two million women. That would raise a significant barrier to achieving gender parity in leadership roles in years to come.
  • The global economic contractions resulting from the COVID-19 pandemic have far exceeded those of the Great Recession that ended in 2009 and have occurred at a much faster rate, hitting all sectors and many of the world’s largest employers.
  • Two important issues facing healthcare providers. First, similarities in flu and COVID-19 symptoms could lead to a threefold spike in demand for COVID-19 testing as flu season in the Northern Hemisphere approaches.
  • Second, the crisis has also led to a surgical backlog for elective procedures because of lack of hospital capacity, workforce shortages, and new safety protocols.

SOURCE

https://www.mckinsey.com/business-functions/risk/our-insights/covid-19-implications-for-business?cid=other-eml-alt-mip-mck

 

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Approaches and Solutions for Management of the COVID Pandemic

Reporter: Aviva Lev- Ari, PhD, RN and Stephen J. Williams, PhD  
 
 
 
 
 
October 8, 2020 N Engl J Med 2020; 383:1479-1480 DOI: 10.1056/NEJMe2029812

 

Dying in a Leadership Vacuum

CONTINUE TO READ AT THE SOURCE N Engl J Med 2020; 383:1479-1480 DOI: 10.1056/NEJMe2029812   Janice Hopkins Tanne. (2020) Covid 19: NEJM and former CDC director launch stinging attacks on US response. BMJ, m3925. BMJ 2020;371:m3925

Covid 19: NEJM and former CDC director launch stinging attacks on US response

Janice Hopkins Tanne Author affiliations

The US is “dying in a leadership vacuum,” in responding to the covid-19 pandemic, the New England Journal of Medicine has said in an editorial.

“Our leaders have failed. They have taken a crisis and turned it into a tragedy,” the NEJM editors said. US leaders are “dangerously incompetent,” have undercut trust in science and in government,” and should be voted out,1 the journal said.

The intervention came as a former director of the Centers for Disease Control and Prevention (CDC) suggested the current CDC director should update staff in writing about the agency’s failings, apologise, and resign.23

The US leads the world in the death rate from covid-19, which is far higher than larger countries and those with less sophisticated technology and health services, the editors said.

“We have failed at almost every step,” they wrote, describing problems with supplies of personal protective equipment, delays in testing, and failure to employ quarantine, isolation, and social distancing appropriately and quickly. Government inaction has led to business losses and unemployment.

Earlier, William Foege, former director of the CDC and a leader in smallpox eradication, criticised the US response and the failure of the CDC. He sent a letter to Robert Redfield, the current CDC director, asking him to write to CDC employees describing the White House’s failure to put the CDC in charge of the covid-19 pandemic and then resign. A letter, he wrote, would be on the record.

Foege called the US response to the pandemic “a slaughter and not just a political dispute” that had turned the CDC’s reputation from “gold to tarnished brass.”

Foege is emeritus presidential distinguished professor of international health at Emory University. He was director of the Carter Center’s Task Force for Child Survival and senior medical advisor to the Bill and Melinda Gates Foundation. President Barack Obama awarded him the Presidential Medal of Freedom, the nation’s highest civilian honour, in 2012. His private letter, written on 23 September, was published by USA Today on 7 October.

Redfield, a virologist with expertise in HIV/AIDS and a clinician, served in the US Army’s medical corps. He co-founded the University of Maryland’s Institute of Human Virology and was chief of infectious diseases at the university’s medical school.

Foege wrote, “You don’t want to be seen, in the future, as forsaking your role as servant to the public in order to become a servant to a corrupt president. You could send a letter to all CDC employees (a letter leaves a record and avoids the chance of making a mistake with a speech) laying out the facts. The White House will, of course, respond with fury. But you will have right on your side. Like Martin Luther, you can say, ‘Here I stand, I cannot do otherwise.’”

Among the truths that need to be faced, Foege said, are that, despite White House spin attempts, the failure of the US public health system is because of “the incompetence and illogic of the White House programme.”

The White House failed to put the CDC in charge of the pandemic, violating rules of public health so that “people and the media go to the academic community for truth, rather than to CDC,” Foege’s letter says. Unlike former responses to health crises, there has been no federal plan, “resulting in 50 states developing their own plans, often in competition.”

The need to form coalitions to fight the pandemic “has been ignored as the president thrives instead on creating divisions, and the need for global cooperation has been squandered by an ‘America first’ policy. The best decisions are based on the best science while the best results are based on the best management. The White House has rejected both science and good management,” Foege wrote.

Foege, the CDC, Redfield, and the White House have not publicly commented on the letter.

References
  SOURCES for the NEJM https://www.nejm.org/doi/full/10.1056/NEJMe2029812?query=recirc_mostViewed_railB_article https://www.nejm.org/doi/full/10.1056/NEJMe2029812#.X39d2y9tN84.twitter Janice Hopkins Tanne. (2020) Covid 19: NEJM and former CDC director launch stinging attacks on US response. BMJ, m3925. BMJ 2020;371:m3925

Covid 19: NEJM and former CDC director launch stinging attacks on US response

BMJ 2020371 doi: https://doi.org/10.1136/bmj.m3925 (Published 08 October 2020) Cite this as: BMJ 2020;371:m3925   References
  1. Johns Hopkins University Coronavirus Resource Center. COVID-19 dashboard by the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University (https://coronavirus.jhu.edu/map.html. opens in new tab).

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  2. Total number of COVID-19 tests per confirmed case, September 14, 2020. Our World in Data (https://ourworldindata.org/grapher/number-of-covid-19-tests-per-confirmed-case. opens in new tab).

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  3. McGinley L, Abutaleb L, Johnson CY. Inside Trump’s pressure campaign on federal scientists over a Covid-19 treatment. Washington Post. August 302020 (https://www.washingtonpost.com/health/convalescent-plasma-treatment-covid19-fda/2020/08/29/e39a75ec-e935-11ea-bc79-834454439a44_story.html. opens in new tab).

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Related Articles

 

Other related articles published in this Open Access Online Scientific Journal include the following EIGHT topics we cover since March 14, 2020 on LPBI Group’s Coronavirus PORTAL

https://pharmaceuticalintelligence.com/coronavirus-portal/

Eight COVID-19 Topics Covered and Lead Curators are:

  1. Breakthrough News Corner
  2. Development of Medical Counter-measures for 2019-nCoV, CoVid19, Coronavirus
  3. An Epidemiological Approach Stephen J. Williams, PhD and Aviva Lev-Ari, PhD, RN Lead Curators – e–mail Contacts: sjwilliamspa@comcast.net and avivalev-ari@alum.berkeley.edu
  4. Community Impact Stephen J. Williams, PhD and Irina Robu, PhD Lead Curators – e–mail Contacts: irina.stefania@gmail.com and sjwilliamspa@comcast.net
  5. Economic Impact of The Coronavirus Pandemic Dr. Joel Shertok, PhD Lead Curator – e–mail Contact: jshertok@processindconsultants.com
  6. Voices of Global Citizens: Impact of The Coronavirus Pandemic, Gail S. Thornton, M.A. Lead Curator – e–mail Contact: gailsthornton@yahoo.com
  7. Diagnosis of Coronavirus Infection by Medical Imaging and Cardiovascular Impacts of Viral Infection, Aviva Lev-Ari, PhD, RN Lead Curator e-mail contact: avivalev-ari@alum.berkeley.edu
  8. Key Opinion Leaders Followed by LPBI Aviva Lev-Ari, PhD, RN and Dr. Ofer Markman, PhD Lead Curators e-mail contacts: oferm2015@gmail.com and avivalev-ari@alum.berkeley.edu

 

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The lessons from the Covid-19 response, according to Anthony Fauci

Reporter : Irina Robu, PhD

 

UPDATED on 10/18/2020

 

 

Since COVID-19 was declared an international pandemic, the world has learned difficult lessons according to Dr. Anthony Fauci. They are as follows:

  • Don’t understand the impact of the pandemic. Don’t ever estimate [an outbreak] as it evolves and don’t try to look at the rosy side of things.
  • Always do scientifically sound research.
  • Adapt to new information. If you look at what we knew in February compared to what we know now [about Covid-19], there really are a lot of differences. The role of masks, the role of aerosol, the role of indoor vs. outdoors, closed spaces. You’ve just got to be humble enough to realize that we don’t know it all from the get-go and even as we get into it.
  • Address existing health care disparities. There is a high number of hospitalizations with COVID within African-American and Latin community.

SOURCE

https://www.statnews.com/2020/09/10/anthony-fauci-lessons-learned-covid19-pandemic

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